Devices

Device Recall Bivona Laryngectomy Tube

Model / Serial
Lots 1055779, 1245930, 1263830, 1302670, 1310500, 1324570, 1351420, 1351480, G654810, G689730 and G726388.
Product Classification
Ear, Nose, and Throat Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide, including USA, Canada, Netherlands and United Kingdom.
Product Description
Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.
Manufacturer
Smiths Medical ASD, Inc.
1 Event
- Recall of Device Recall Bivona Laryngectomy Tube

Manufacturer

Smiths Medical ASD, Inc.

Manufacturer Address
Smiths Medical ASD, Inc., 5700 W 23rd Ave, Gary IN 46406-2617
Manufacturer Parent Company (2017)
Smiths Group Plc
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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